FDA 510(k) Application Details - K240983

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K240983
Device Name	Powered Laser Surgical Instrument
Applicant	Quanta System SpA Via Acquedotto 109 Samarate 21017 IT Other 510(k) Applications for this Company
Contact	Dario Bandiera Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2024
Decision Date	06/06/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review